Nutrition, HealthyNHTNCT05542537
Nurturing Healthy Teachers
A study testing Brighter Bites (BB) Produce Distribution, Brighter Bites (BB) Nutrition Education and Create Healthy Futures (CHF) Weekly Wellness Groups in people with Nutrition, Healthy and Mental Health Wellness 1, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this trial is to compare the impact of a fruit and vegetable access plus nutrition education intervention to a nutrition education-only control on the health, well-being, and food security of early care and education (ECE) professionals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Mental Health Wellness 1, Diabetes Mellitus Risk
- What is being tested?
- Brighter Bites (BB) Produce Distribution, Brighter Bites (BB) Nutrition Education and Create Healthy Futures (CHF) Weekly Wellness Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to 20 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employed as a pre-K or kindergarten teaching staff at the participating study schools in the 2022-2023 school year.
- Ability to read English at the 4th grade reading level
- Ability to complete study measures
- Have at least 25 eligible early childhood education (ECE) professionals
Who cannot join
- Have recently (in the past 6 months) or are currently participating in an exercise or weight loss program
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Nurturing Healthy Teachers: A Cluster-RCT to Improve the Health, Well-being, and Food Security of Early Care and Education (ECE) Professionals
The purpose of this trial is to compare the impact of a fruit and vegetable access plus nutrition education intervention to a nutrition education-only control on the health, well-being, and food security of early care and education (ECE) professionals. The intervention, called Nurturing Healthy Teachers, combines strategies from two evidence-based programs - Create Healthy Futures (CHF) and Brighter Bites (BB).
Read the detailed description
The purpose of this trial is to evaluate the impact of the Nurturing Healthy Teachers program on food insecurity, dietary behaviors, mental health, and cardiometabolic health among early care and education (ECE) professionals who teach Pre-Kindergarten or Kindergarten. Nurturing Healthy Teachers is a novel, comprehensive program that combines strategies from two evidence-based programs - Brighter Bites (implemented by Brighter Bites 501c3 non-profit) and Create Healthy Futures (implemented by Penn State Better Kid Care).
- Brighter Bites (BB) is a 501c3 non-profit organization that implements an evidence-based coordinated school health program that combines access to fresh produce and nutrition education proven to improve dietary intake among preschool and elementary school teachers, low-income children, and their families. For 16 weeks in the school year, Brighter Bites teachers and families receive a weekly distribution of about 20 lbs (50 servings) of primarily donated fresh vegetables, plus weekly healthy recipe tastings, and nutrition education. The program has proven effectiveness at engaging teachers, parents, increasing healthy dietary behaviors and improving the school and home nutrition environment of low-income elementary school children in the short-term.
- Developed and implemented by Penn State Extension Better Kid Care (BKC), Create Healthy Futures (CHF) is a web-based nutrition education program that targets nutrition knowledge, self-efficacy, mindfulness, and social support to create healthy habits among teachers. CHF also includes facilitated group meetings to reinforce information from the online modules.
The trial will be conducted in 30 elementary schools that have pre-Kindergarten and Kindergarten classes that serve predominantly low-income families in Houston. Schools in the intervention arm (n=15) will receive Brighter Bites plus the complete Create Healthy Futures program including online modules and in-person meetings, and they will be drawn from schools that are already scheduled to receive Brighter Bites during the 2022-2023 school year. Schools in the control arm (n=15) will only receive passive access to the online modules of the Create Healthy Futures program, and they will be drawn from remaining schools across the district, as long as they have not participated in Brighter Bites in the previous two years. The intervention and control programs will be implemented over one school year (9months). Brighter Bites non-profit organization and Penn State Better Kid Care will implement the Nurturing Healthy Teachers program, while UTHealth School of Public Health investigators will conduct the evaluation of the program.
- Being tested
- Brighter Bites (BB) Produce Distribution, Brighter Bites (BB) Nutrition Education, Create Healthy Futures (CHF) Weekly Wellness Groups, Create Healthy Futures (CHF) Web-Based Module
- Keywords
- food insecurity, nutrition, healthy eating, wellness, teachers
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brighter Bites (BB) Produce DistributionBehavioural
For 16 weeks in the school year, teachers in participating program schools will receive distributions of 8-10 different types of produce items.
Brighter Bites (BB) Nutrition EducationBehavioural
Brighter Bites Nutrition Education will consist of recipes, food preparation and storage ideas, and tips and tools to budget and plan meals. Teachers will be trained in a nutrition education curriculum, which will be implemented in the program schools as part of the BB program.
Create Healthy Futures (CHF) Weekly Wellness GroupsBehavioural
Peer-facilitators will lead virtual weekly group discussions. Penn State Better Kid Care will train the wellness facilitators.
Create Healthy Futures (CHF) Web-Based ModuleBehavioural
Create Healthy Futures Web-Based Module is self-paced and focuses on the following topics: 1) Introduction, 2) Challenges of the food environment, 3) Nutrition and your health, 4) Food culture reform, and 5) Providers' role in creating healthy futures. The Create Healthy Futures module utilizes several educational methods to increase interactivity and engagement, including video footage of content experts, reflection activities, downloadable handouts, and action planning. Each chapter takes approximately 30-40 minutes to complete. The program is delivered on the Better Kid Care On Demand platform, an asynchronous learning management system that provides professional development training for teachers in all 50 states and 69 countries.
| Study group | Role | What they receive |
|---|---|---|
| BB Produce Distribution + BB Nutrition Education + CHF Weekly Wellness Groups + CHF Web-Based Module | Experimental | BB is Brighter Bites. CHF is Create Healthy Futures. Receives: Behavioral: Brighter Bites (BB) Produce Distribution; Behavioral: Brighter Bites (BB) Nutrition Education; Behavioral: Create Healthy Futures (CHF) Weekly Wellness Groups; Behavioral: Create Healthy Futures (CHF) Web-Based Module |
| CHF Web-Based Module | Active comparator | CHF is Create Healthy Futures. Receives: Behavioral: Create Healthy Futures (CHF) Web-Based Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity survey
Household Food insecurity will be measured on an electronically administered using the 10-item self-report previously validated U.S. Department of Agriculture food insecurity survey. The survey will measure food insecurity over the past 30 days. The total score is the sum of affirmative responses to the 10 questions, with a total score range of 0-10. Scores indicate the following about extent of food insecurity:
- score of zero-High food security
- score of 1-2-Marginal food security
- score of 3-5-Low food security
- score of 6-10-Very low food security
Measured: baseline
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
Household Food insecurity will be measured on an electronically administered using the 10-item self-report previously validated U.S. Department of Agriculture food insecurity survey. The survey will measure food insecurity over the past 30 days. The total score is the sum of affirmative responses to the 10 questions, with a total score range of 0-10. Scores indicate the following about extent of food insecurity:
- score of zero-High food security
- score of 1-2-Marginal food security
- score of 3-5-Low food security
- score of 6-10-Very low food security
Measured: 4 months
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
Household Food insecurity will be measured on an electronically administered using the 10-item self-report previously validated U.S. Department of Agriculture food insecurity survey. The survey will measure food insecurity over the past 30 days. The total score is the sum of affirmative responses to the 10 questions, with a total score range of 0-10. Scores indicate the following about extent of food insecurity:
- score of zero-High food security
- score of 1-2-Marginal food security
- score of 3-5-Low food security
- score of 6-10-Very low food security
Measured: 9 months
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
Household Food insecurity will be measured on an electronically administered using the 10-item self-report previously validated U.S. Department of Agriculture food insecurity survey. The survey will measure food insecurity over the past 30 days. The total score is the sum of affirmative responses to the 10 questions, with a total score range of 0-10. Scores indicate the following about extent of food insecurity:
- score of zero-High food security
- score of 1-2-Marginal food security
- score of 3-5-Low food security
- score of 6-10-Very low food security
Measured: 14 months
Secondary outcomes (28)
Dietary intake as assessed by self-report survey
Dietary intake will be self-reported on an electronically administered survey using a food frequency screener. The survey items will measure the frequency of consumption of various foods including fruits, vegetables, whole grains, protein, water, beverages, desserts, processed food, and candy. Data will be reported categorically as the number of times the surveyed foods were consumed.
Measured: baseline
Dietary intake as assessed by self-report survey
Dietary intake will be self-reported on an electronically administered survey using a food frequency screener. The survey items will measure the frequency of consumption of various foods including fruits, vegetables, whole grains, protein, water, beverages, desserts, processed food, and candy. Data will be reported categorically as the number of times the surveyed foods were consumed.
Measured: 9 months
Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
The Generalized Anxiety Disorder 7-item (GAD) survey has a total score from 0 to 21, with a higher score indicating greater anxiety.
Measured: baseline
Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
The Generalized Anxiety Disorder 7-item (GAD) survey has a total score from 0 to 21, with a higher score indicating greater anxiety.
Measured: 9 months
Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
The Generalized Anxiety Disorder 7-item (GAD) survey has a total score from 0 to 21, with a higher score indicating greater anxiety.
Measured: 14 months
Anxiety impact as assessed by the impact item of the GAD-7 survey
For participants who scored 1 or above on the GAD-7, they will be asked how difficult the anxiety-related issues have made it to do work, take care of things at home, or get along with other people. Data will be reported categorically as number of participants who answered: Not difficult at all; Somewhat difficult; Very difficult; Extremely difficult; Prefer not to say.
Measured: baseline
Anxiety impact as assessed by the impact item of the GAD-7 survey
For participants who scored 1 or above on the GAD-7, they will be asked how difficult the anxiety-related issues have made it to do work, take care of things at home, or get along with other people. Data will be reported categorically as number of participants who answered: Not difficult at all; Somewhat difficult; Very difficult; Extremely difficult; Prefer not to say.
Measured: 9 months
Anxiety impact as assessed by the impact item of the GAD-7 survey
For participants who scored 1 or above on the GAD-7, they will be asked how difficult the anxiety-related issues have made it to do work, take care of things at home, or get along with other people. Data will be reported categorically as number of participants who answered: Not difficult at all; Somewhat difficult; Very difficult; Extremely difficult; Prefer not to say.
Measured: 14 months
Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
The Patient Health 9-item Questionnaire (PHQ-9) has a total score of 0 to 27, with a higher score indicating greater depression.
Measured: baseline
Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
The Patient Health 9-item Questionnaire (PHQ-9) has a total score of 0 to 27, with a higher score indicating greater depression.
Measured: 9 months
Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
The Patient Health 9-item Questionnaire (PHQ-9) has a total score of 0 to 27, with a higher score indicating greater depression.
Measured: 14 months
Depression impact as assessed by the impact item of the PHQ-9
For participants who scored 1 or above on the PHQ-9, they will be asked how difficult the depression-related issues have made it to do work, take care of things at home, or get along with other people. Data will be reported categorically as number of participants who answered: Not difficult at all; Somewhat difficult; Very difficult; Extremely difficult; Prefer not to say.
Measured: baseline
Depression impact as assessed by the impact item of the PHQ-9
For participants who scored 1 or above on the PHQ-9, they will be asked how difficult the depression-related issues have made it to do work, take care of things at home, or get along with other people. Data will be reported categorically as number of participants who answered: Not difficult at all; Somewhat difficult; Very difficult; Extremely difficult; Prefer not to say.
Measured: 9 months
Depression impact as assessed by the impact item of the PHQ-9
For participants who scored 1 or above on the PHQ-9, they will be asked how difficult the depression-related issues have made it to do work, take care of things at home, or get along with other people. Data will be reported categorically as number of participants who answered: Not difficult at all; Somewhat difficult; Very difficult; Extremely difficult; Prefer not to say.
Measured: 14 months
Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
The 5-item World Health Organization Well-Being Index (WHO-5) has a total score or 0 -25, with a higher score indicating greater well-being.
Measured: baseline
Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
The 5-item World Health Organization Well-Being Index (WHO-5) has a total score or 0 -25, with a higher score indicating greater well-being.
Measured: 9 months
Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
The 5-item World Health Organization Well-Being Index (WHO-5) has a total score or 0 -25, with a higher score indicating greater well-being.
Measured: 14 months
General health as assessed by the general health item of the Centers for Disease Control and Prevention (CDC) Health-related quality of life (HRQoL) 4-item questionnaire (CDC HRQoL-4)
Only one item on the CDC HRQoL-4 will be asked, and this is the item related to general health. Participants will be asked if they would say that in general that their health is Excellent, Very good, Good, Fair, Poor, or Prefer not to say. Data will be reported categorically as number of participants who answered: Excellent; Very good; Good; Fair; Poor; Prefer not to say.
Measured: baseline
General health as assessed by the general health item of the Centers for Disease Control and Prevention (CDC) Health-related quality of life (HRQoL) 4-item questionnaire (CDC HRQoL-4)
Only one item on the CDC HRQoL-4 will be asked, and this is the item related to general health. Participants will be asked if they would say that in general that their health is Excellent, Very good, Good, Fair, Poor, or Prefer not to say. Data will be reported categorically as number of participants who answered: Excellent; Very good; Good; Fair; Poor; Prefer not to say.
Measured: 9 months
General health as assessed by the general health item of the Centers for Disease Control and Prevention (CDC) Health-related quality of life (HRQoL) 4-item questionnaire (CDC HRQoL-4)
Only one item on the CDC HRQoL-4 will be asked, and this is the item related to general health. Participants will be asked if they would say that in general that their health is Excellent, Very good, Good, Fair, Poor, or Prefer not to say. Data will be reported categorically as number of participants who answered: Excellent; Very good; Good; Fair; Poor; Prefer not to say.
Measured: 14 months
Glycosylated hemoglobin (HbA1c) level as assessed by blood test
Finger stick blood samples will be obtained from teachers in the school, and HbA1c level in the blood sample will be analyzed.
Measured: baseline
Glycosylated hemoglobin (HbA1c) level as assessed by blood test
Finger stick blood samples will be obtained from teachers in the school, and HbA1c level in the blood sample will be analyzed.
Measured: 9 months
Blood pressure (systolic) as assessed by automated oscillometric device
Blood pressure measurements will be taken using an automated oscillometric device.
Measured: baseline
Blood pressure (systolic) as assessed by automated oscillometric device
Blood pressure measurements will be taken using an automated oscillometric device.
Measured: 9 months
Blood pressure (diastolic) as assessed by automated oscillometric device
Blood pressure measurements will be taken using an automated oscillometric device.
Measured: baseline
Blood pressure (diastolic) as assessed by automated oscillometric device
Blood pressure measurements will be taken using an automated oscillometric device.
Measured: 9 months
Skin carotenoid level as assessed by The Veggie Meter
Skin carotenoid level will be assessed by The Veggie Meter, which is a small, portable non-invasive device that can be clipped to the finger briefly to detect skin carotenoid concentrations in ∼15-20 seconds for a single reading.
Measured: baseline
Skin carotenoid level as assessed by The Veggie Meter
Skin carotenoid level will be assessed by The Veggie Meter, which is a small, portable non-invasive device that can be clipped to the finger briefly to detect skin carotenoid concentrations in ∼15-20 seconds for a single reading.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start4 Nov 2022
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Brighter Bites, Penn State Better Kid Care, University of Texas at Austin, Vitamix Foundation
- Responsible party
- Principal investigator, Shreela V Sharma, The University of Texas Health Science Center, Houston
- Investigators
- Shreela V Sharma, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542537
- Sponsor's protocol ID
- HSC-SPH-22-0276
- Acronym
- NHT
- Status last verified
- Jul 2025
- First submitted
- 12 Sep 2022
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurturing Healthy Teachers: A Cluster-RCT to Improve the Health, Well-being, and Food Security of Early Care and Education (ECE) Professionals
- ClinicalTrials.gov ID
- NCT05542537
- Acronym / sponsor ID
- NHT / HSC-SPH-22-0276
- Keywords
- food insecurity, nutrition, healthy eating, wellness, teachers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Brighter Bites, Penn State Better Kid Care, University of Texas at Austin, Vitamix Foundation
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to compare the impact of a fruit and vegetable access plus nutrition education intervention to a nutrition education-only control on the health, well-being, and food security of early care and education (ECE) professionals. The intervention, called Nurturing Healthy Teachers, combines strategies from two evidence-based programs - Create Healthy Futures (CHF) and Brighter Bites (BB).
Detailed description
The purpose of this trial is to evaluate the impact of the Nurturing Healthy Teachers program on food insecurity, dietary behaviors, mental health, and cardiometabolic health among early care and education (ECE) professionals who teach Pre-Kindergarten or Kindergarten. Nurturing Healthy Teachers is a novel, comprehensive program that combines strategies from two evidence-based programs - Brighter Bites (implemented by Brighter Bites 501c3 non-profit) and Create Healthy Futures (implemented by Penn State Better Kid Care).
- Brighter Bites (BB) is a 501c3 non-profit organization that implements an evidence-based coordinated school health program that combines access to fresh produce and nutrition education proven to improve dietary intake among preschool and elementary school teachers, low-income children, and their families. For 16 weeks in the school year, Brighter Bites teachers and families receive a weekly distribution of about 20 lbs (50 servings) of primarily donated fresh vegetables, plus weekly healthy recipe tastings, and nutrition education. The program has proven effectiveness at engaging teachers, parents, increasing healthy dietary behaviors and improving the school and home nutrition environment of low-income elementary school children in the short-term.
- Developed and implemented by Penn State Extension Better Kid Care (BKC), Create Healthy Futures (CHF) is a web-based nutrition education program that targets nutrition knowledge, self-efficacy, mindfulness, and social support to create healthy habits among teachers. CHF also includes facilitated group meetings to reinforce information from the online modules.
The trial will be conducted in 30 elementary schools that have pre-Kindergarten and Kindergarten classes that serve predominantly low-income families in Houston. Schools in the intervention arm (n=15) will receive Brighter Bites plus the complete Create Healthy Futures program including online modules and in-person meetings, and they will be drawn from schools that are already scheduled to receive Brighter Bites during the 2022-2023 school year. Schools in the control arm (n=15) will only receive passive access to the online modules of the Create Healthy Futures program, and they will be drawn from remaining schools across the district, as long as they have not participated in Brighter Bites in the previous two years. The intervention and control programs will be implemented over one school year (9months). Brighter Bites non-profit organization and Penn State Better Kid Care will implement the Nurturing Healthy Teachers program, while UTHealth School of Public Health investigators will conduct the evaluation of the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BB Produce Distribution + BB Nutrition Education + CHF Weekly Wellness Groups + CHF Web-Based Module | Experimental | Behavioral: Brighter Bites (BB) Produce Distribution, Behavioral: Brighter Bites (BB) Nutrition Education, Behavioral: Create Healthy Futures (CHF) Weekly Wellness Groups, Behavioral: Create Healthy Futures (CHF) Web-Based ModuleBB is Brighter Bites. CHF is Create Healthy Futures. |
| CHF Web-Based Module | Active comparator | Behavioral: Create Healthy Futures (CHF) Web-Based ModuleCHF is Create Healthy Futures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Employed as a pre-K or kindergarten teaching staff at the participating study schools in the 2022-2023 school year.
- Ability to read English at the 4th grade reading level
- Ability to complete study measures
- Have at least 25 eligible early childhood education (ECE) professionals
Key exclusion criteria (1 listed)
- Have recently (in the past 6 months) or are currently participating in an exercise or weight loss program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brighter Bites (BB) Produce DistributionFor 16 weeks in the school year, teachers in participating program schools will receive distributions of 8-10 different types of produce items. | Behavioural | BB Produce Distribution + BB Nutrition Education + CHF Weekly Wellness Groups + CHF Web-Based Module |
| Brighter Bites (BB) Nutrition EducationBrighter Bites Nutrition Education will consist of recipes, food preparation and storage ideas, and tips and tools to budget and plan meals. Teachers will be trained in a nutrition education curriculum, which will be implemented in the program schools as part of the BB program. | Behavioural | BB Produce Distribution + BB Nutrition Education + CHF Weekly Wellness Groups + CHF Web-Based Module |
| Create Healthy Futures (CHF) Weekly Wellness GroupsPeer-facilitators will lead virtual weekly group discussions. Penn State Better Kid Care will train the wellness facilitators. | Behavioural | BB Produce Distribution + BB Nutrition Education + CHF Weekly Wellness Groups + CHF Web-Based Module |
| Create Healthy Futures (CHF) Web-Based ModuleCreate Healthy Futures Web-Based Module is self-paced and focuses on the following topics: 1) Introduction, 2) Challenges of the food environment, 3) Nutrition and your health, 4) Food culture reform, and 5) Providers' role in creating healthy futures. The Create Healthy Futures module utilizes several educational methods to increase interactivity and engagement, including video footage of content experts, reflection activities, downloadable handouts, and action planning. Each chapter takes approximately 30-40 minutes to complete. The program is delivered on the Better Kid Care On Demand platform, an asynchronous learning management system that provides professional development training for teachers in all 50 states and 69 countries. | Behavioural | BB Produce Distribution + BB Nutrition Education + CHF Weekly Wellness Groups + CHF Web-Based Module, CHF Web-Based Module |
Primary outcome
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity survey
Time frame: baseline
Household Food insecurity will be measured on an electronically administered using the 10-item self-report previously validated U.S. Department of Agriculture food insecurity survey. The survey will measure food insecurity over the past 30 days. The total score is the sum of affirmative responses to the 10 questions, with a total score range of 0-10. Scores indicate the following about extent of food insecurity: * score of zero-High food security * score of 1-2-Marginal food security * score of 3-5-Low food security * score of 6-10-Very low food security
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
Time frame: 4 months
Household Food insecurity will be measured on an electronically administered using the 10-item self-report previously validated U.S. Department of Agriculture food insecurity survey. The survey will measure food insecurity over the past 30 days. The total score is the sum of affirmative responses to the 10 questions, with a total score range of 0-10. Scores indicate the following about extent of food insecurity: * score of zero-High food security * score of 1-2-Marginal food security * score of 3-5-Low food security * score of 6-10-Very low food security
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
Time frame: 9 months
Household Food insecurity will be measured on an electronically administered using the 10-item self-report previously validated U.S. Department of Agriculture food insecurity survey. The survey will measure food insecurity over the past 30 days. The total score is the sum of affirmative responses to the 10 questions, with a total score range of 0-10. Scores indicate the following about extent of food insecurity: * score of zero-High food security * score of 1-2-Marginal food security * score of 3-5-Low food security * score of 6-10-Very low food security
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity measure
Time frame: 14 months
Household Food insecurity will be measured on an electronically administered using the 10-item self-report previously validated U.S. Department of Agriculture food insecurity survey. The survey will measure food insecurity over the past 30 days. The total score is the sum of affirmative responses to the 10 questions, with a total score range of 0-10. Scores indicate the following about extent of food insecurity: * score of zero-High food security * score of 1-2-Marginal food security * score of 3-5-Low food security * score of 6-10-Very low food security
28 secondary outcomes
Dietary intake as assessed by self-report survey
Time frame: baseline
Dietary intake as assessed by self-report survey
Time frame: 9 months
Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
Time frame: baseline
Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
Time frame: 9 months
Anxiety as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) survey
Time frame: 14 months
Anxiety impact as assessed by the impact item of the GAD-7 survey
Time frame: baseline
Anxiety impact as assessed by the impact item of the GAD-7 survey
Time frame: 9 months
Anxiety impact as assessed by the impact item of the GAD-7 survey
Time frame: 14 months
Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
Time frame: baseline
Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
Time frame: 9 months
Depression as assessed by the Patient Health 9-item Questionnaire (PHQ-9)
Time frame: 14 months
Depression impact as assessed by the impact item of the PHQ-9
Time frame: baseline
Depression impact as assessed by the impact item of the PHQ-9
Time frame: 9 months
Depression impact as assessed by the impact item of the PHQ-9
Time frame: 14 months
Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
Time frame: baseline
Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
Time frame: 9 months
Well-being as assessed by the 5-item World Health Organization Well-Being Index (WHO-5)
Time frame: 14 months
General health as assessed by the general health item of the Centers for Disease Control and Prevention (CDC) Health-related quality of life (HRQoL) 4-item questionnaire (CDC HRQoL-4)
Time frame: baseline
General health as assessed by the general health item of the Centers for Disease Control and Prevention (CDC) Health-related quality of life (HRQoL) 4-item questionnaire (CDC HRQoL-4)
Time frame: 9 months
General health as assessed by the general health item of the Centers for Disease Control and Prevention (CDC) Health-related quality of life (HRQoL) 4-item questionnaire (CDC HRQoL-4)
Time frame: 14 months
Glycosylated hemoglobin (HbA1c) level as assessed by blood test
Time frame: baseline
Glycosylated hemoglobin (HbA1c) level as assessed by blood test
Time frame: 9 months
Blood pressure (systolic) as assessed by automated oscillometric device
Time frame: baseline
Blood pressure (systolic) as assessed by automated oscillometric device
Time frame: 9 months
Blood pressure (diastolic) as assessed by automated oscillometric device
Time frame: baseline
Blood pressure (diastolic) as assessed by automated oscillometric device
Time frame: 9 months
Skin carotenoid level as assessed by The Veggie Meter
Time frame: baseline
Skin carotenoid level as assessed by The Veggie Meter
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shreela V Sharma, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brighter Bites (BB) Produce Distribution, Brighter Bites (BB) Nutrition Education and Create Healthy Futures (CHF) Weekly Wellness Groups in people with Nutrition, Healthy and Mental Health Wellness 1, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity survey (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025; AzTrials last refreshed its copy on 28 Oct 2026.